MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-50-100-120-P6

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation was unable to determine a cause for the reported entrapment and tip separation resulting in unexpected medical intervention.It may be possible that the thumbslide was not retracted to the start position and the system lock was not locked prior to removing the delivery system causing the tip to catch on the stent, anatomy or introducer sheath during removal; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a superficial femoral artery.Post-stent implantation, while removing the delivery system of a 5x100mm supera resistance was met with the guide wire when the nose cone separated.The supera delivery system was able to be removed and then a snare was used to retrieve the separated tip.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11930395
• MDR Text Key: 254259718
• Report Number: 2024168-2021-04622
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: S-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 0031961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 58